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Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel

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ClinicalTrials.gov Identifier: NCT00516724
Recruitment Status : Active, not recruiting
First Posted : August 15, 2007
Last Update Posted : February 28, 2018
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with carboplatin and/or Paclitaxel chemotherapy

Condition or disease Intervention/treatment Phase
Triple Negative Metastatic Breast Cancer Advanced Ovarian Cancer Carboplatin Paclitaxel Drug: KU-0059436 (AZD2281)(PARP inhibitor) Drug: Carboplatin Drug: Paclitaxel Drug: Paclitaxel + Carboplatin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label Study to Assess the Safety and Tolerability of KU-0059436 in Combination With Carboplatin, KU-0059436 in Combination With a Paclitaxel/Carboplatin T/C Doublet and KU-0059436 in Combination With Paclitaxel in the Treatment of Patients With Advanced Solid Tumours
Actual Study Start Date : June 29, 2007
Primary Completion Date : January 4, 2013
Estimated Study Completion Date : December 28, 2018

Arm Intervention/treatment
Experimental: 1
Carboplatin + KU-0059436
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Other Name: Olaparib
Drug: Carboplatin
intravenous injection
Other Names:
  • Paraplatin®
Experimental: 2.
Paclitaxel + KU-0059436
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Other Name: Olaparib
Drug: Paclitaxel
Intravenous injection
Experimental: 3.
Paclitaxel, Carboplatin + KU-0059436
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Other Name: Olaparib
Drug: Paclitaxel + Carboplatin
Intravenous injection

Primary Outcome Measures :
  1. To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin [ Time Frame: assessed at each visit ]

Secondary Outcome Measures :
  1. To identify the dose limiting toxicity of the combination therapy [ Time Frame: assessed at each visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patients with a histologically or cytologically diagnosed malignant solid tumour
  • Adequate bone marrow, hepatic and renal function
  • Performance status of no more than 2 ( ECOG scale).

Exclusion Criteria:

  • Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry
  • Major surgery with 4 weeks of entering the study and must have recovered from effects of the major surgery
  • More than two previous courses of platinum-containing chemotherapy
  • Heavily pre-treated patients(> 2 courses of previous chemotherapy and/or extensive irradiation leading to bone marrow deficiency) will be excluded from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516724

Research Site
Brussels, Belgium
Research Site
Amsterdam, Netherlands
Research Site
Rotterdam, Netherlands
United Kingdom
Research Site
Sutton, Surrey, United Kingdom
Sponsors and Collaborators
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Dr Johann de Bono, MD Cancer Research UK, The Institute of Cancer Research, London, UK
Principal Investigator: Prof Jan HM Schellens The Netherlands Cancer Institute, Amsterdam, The Netherlands

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00516724     History of Changes
Other Study ID Numbers: KU36-96
First Posted: August 15, 2007    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by AstraZeneca:
malignant solid tumours
Poly(ADP ribose) polymerases

Additional relevant MeSH terms:
Albumin-Bound Paclitaxel
Poly(ADP-ribose) Polymerase Inhibitors
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors